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Hot Legs in Heart Failure: Examining Changes in Core Temperature and Lower Limb Blood Flow in lower limb immersion therapy

Hot Legs in Heart Failure: Examining Changes in Core Temperature and Lower Limb Blood Flow

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000460606
Enrollment
12
Registered
2023-05-04
Start date
2024-04-30
Completion date
2026-12-31
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The proposed study will evaluate whether 45 minutes of lower limb heating at 40°C upregulates the thermal response (i.e., core temperature, skin temperature, skin blood flow), vascular function (lower an upper limb) and skeletal muscle tissue oxygenation in HF patients with reduced ejection fraction. A secondary aim is to compare the effect of water height (ankle vs knee) on thermal and vascular function and skeletal muscle of oxygenation. The study will 5 separate visits to Griffith University (approximately 5 hours in total). These will entail an initial baseline assessment (approximately 30 mins), followed by another 4 visits (approximately 60 mins) of lower limb immersion with measurements of core temperature and blood flow. For research visits 2-5, The lower limb immersion will be undertaken at thermoneutral (water temperature 30°C) or hot (water temperature 40°C) lower limb immersion with water up to ankle or knee height.

Interventions

The study intervention will involve 45 minutes of lower limb immersion in either thermoneutral (30°C) or hot water (40°C) bath. We will be using a water tank (container) that will connected with ICool System that will maintain the set temperature throughout 45 mins of immersion. Participants will immerse their both legs in water tank which will be filled up to either knee or ankle height (randomly assigned). During the intervention participants will be seated on the chair with their both leg

The study intervention will involve 45 minutes of lower limb immersion in either thermoneutral (30°C) or hot water (40°C) bath. We will be using a water tank (container) that will connected with ICool System that will maintain the set temperature throughout 45 mins of immersion. Participants will immerse their both legs in water tank which will be filled up to either knee or ankle height (randomly assigned). During the intervention participants will be seated on the chair with their both legs immersed in the water. We have set up the lab with a wall mounted TV screen (at eye level) that participants can watch during 45 minutes of water immersion. Our research team comprises researchers with experience in undertaking hot water immersion interventions, additionally all the interventions will be supervised by a physiotherapist. The water temperature will set to desired level prior to the immersion. We will be using an ICool system that circulates the water between the system and the container to maintain the desired temperature throughout the set period. Water temperature will be monitored throughout the experiment through the digital monitor on the ICool System. As detailed previously, we have undertaken a similar pilot study in establishing this protocol and our team includes physiotherapist, exercise physiologist and clinical physiologists will expertise in undertaking similar interventions in individuals cardiorespiratory conditions. The study will involve 5 experimental visits - a familiarisation visit and 4 experimental visits with a week interval between the visits to allow washout. Visit 1 (familiarisation visit): This visit will involve obtaining the informed written consent and familiarising the participants to the research protocol. Participants will be detailed about all the intervention involved before getting the consent signed. After obtaining the informed written consent, we will obtain the anthropometric measurements and set the height of the table ensuring the comfortable posture while legs are immersed in the water tank. We will also measure the baseline Vascular function and skeletal muscle tissue oxygenation. Visits 2 to 5: during these 4 weekly sessions participants will undertake four 45 mins hot water interventions in random order. The interventions are: (1) Angle height thermoneutral (30 degree C), (2) Ankle height hot (40 degree C), (3) Knee height thermoneutral (30 degree C) and (4) Knee height hot (40 degree C). Each intervention will take 45 mins. Thermal response will be monitored during the intervention and on the completion of each intervention vascular function and skeletal muscle tissue oxygenation will be measured.

Sponsors

Griffith University, Menzies Health Institute Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• A referral to HF rehabilitation • NYHA class I-III, heart failure with reduced ejection fraction HFrEF) • Aged greater than 18 years • No exacerbations of HF-related symptoms or changes in medications within the past 3 months • Free from unstable angina, recent myocardial infarction or severe valvular disease • No skin conditions that would prevent limb immersion in water bath.

Exclusion criteria

• Participants with exacerbation of HF symptoms or changes in medications within the past 3 months • HF participants with unstable angina, recent myocardial infarction or severe valvular disease • HF participants with skin conditions that would prevent limb immersion in water bath • Unable to use the ingestible telemetry pill for measuring core temperature (ie individuals: with surgically implanted electro-medical devices: body mass less than 40kg, with gastrointestinal surgery or disorders (e.g., Chron's, diverticula, motility issues), have expected/scheduled MRI scanning in within 72h of ingestion, are pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026